Cleared Traditional

K120118 - VENTLAB PRESSURECHEK DISOSABLE COLUMN M...

K120118 is an FDA 510(k) clearance for VENTLAB PRESSURECHEK DISOSABLE COLUMN M..., manufactured by Ventlab Corp.. The device is a Class 2 Anesthesiology device with product code CAP cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K120118 · Ventlab Corp. · Anesthesiology device
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May 2012
Decision
128d
Days
Class 2
Risk

K120118 is an FDA 510(k) clearance for the VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Ventlab Corp. (Mocksville, US). The FDA issued a Cleared decision on May 24, 2012 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2600 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ventlab Corp. devices

FDA 510(k) Submission Details - K120118

510(k) Number K120118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2012
Decision Date May 24, 2012
Days to Decision 128 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 140d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAP Device Classification - Class 2, Special Controls

Product Code CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)

All 35
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K120118.
NS 120P-TRS Airway Pressure Gauge
K180510 · Instrumentation Industries, Inc. · May 2019
NAPA LP-15 Airway Pressure Monitor
K172284 · Drw Medical, LLC · Feb 2018
VORTRAN Manometer
K153733 · Vortran Medical Technology 1, Inc. · Sep 2016
VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC
K103639 · Vortran Medical Technology 1, Inc. · Sep 2011
NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS
K081778 · Instrumentation Industries, Inc. · Sep 2008
AMBU DISPOSABLE PRESSURE MANOMETER
K040991 · Ambu, Inc. · Jul 2004